title: MVA-MUC1-IL2 vaccine immunotherapy (TG4010) improves PSA doubling time in patients with prostate cancer with biochemical failure.
abstract: OBJECTIVE
  TG4010 is a recombinant MVA vector expressing the tumor-associated antigen MUC1 and IL2. We explored the effect two schedules of TG4010 on PSA in men with PSA progression.
  
  
  METHODS
  A randomized phase II trial was conducted in 40 patients with PSA progression. Patients had PSA doubling times less than 10 months, with no overt evidence of disease. Patients received either weekly subcutaneous injection (sc) of TG4010 10(8) pfu for 6 weeks, then one injection every 3 weeks or sc injection of TG4010 10(8) pfu every 3 weeks.
  
  
  RESULTS
  The primary endpoint of a 50% decrease in PSA values from baseline was not observed. Nevertheless, 13 of 40 patients had a more than two fold improvement in PSA doubling time. Ten patients had their PSA stabilized for over 8 months. Therapy was well tolerated.
  
  
  CONCLUSIONS
  Although the primary endpoint was not achieved, there is evidence of biologic activity of TG4010 in patients with PSA progression, further investigation in prostate cancer is warranted.
authors.affiliation: Department of Solid Tumor Oncology Taussig Cancer Center, Cleveland Clinic, Cleveland, OH, USA. Dreicer@ccf.org
authors.forename: R
authors.initials: R
authors.lastname: Dreicer
authors.forename: W M
authors.initials: WM
authors.lastname: Stadler
authors.forename: F R
authors.initials: FR
authors.lastname: Ahmann
authors.forename: T
authors.initials: T
authors.lastname: Whiteside
authors.forename: N
authors.initials: N
authors.lastname: Bizouarne
authors.forename: B
authors.initials: B
authors.lastname: Acres
authors.forename: J-M
authors.initials: JM
authors.lastname: Limacher
authors.forename: P
authors.initials: P
authors.lastname: Squiban
authors.forename: A
authors.initials: A
authors.lastname: Pantuck
mesh_terms: D000368:Aged; D019496:Cancer Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018450:Disease Progression; D004334:Drug Administration Schedule; D006801:Humans; D007167:Immunotherapy / Q000379:methods; D007279:Injections, Subcutaneous; D007376:Interleukin-2 / Q000276:immunology; D008297:Male; D008562:Membrane Glycoproteins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D018396:Mucin-1 / Q000276:immunology; D017430:Prostate-Specific Antigen / Q000097:blood / Q000187:drug effects*; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000276:immunology; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D019496:Cancer Vaccines; D007376:Interleukin-2; C060192:MUC1 protein, human; D008562:Membrane Glycoproteins; D018396:Mucin-1; C518275:TG4010; D017430:Prostate-Specific Antigen